SELECT SHOULDER CURVED-BACK PEGGED ALL POLY GLENOIDS

K970567 · Intermedics Orthopedics · KWT · Feb 27, 1997 · Orthopedic

Device Facts

• Record ID: K970567
• Device Name: SELECT SHOULDER CURVED-BACK PEGGED ALL POLY GLENOIDS
• Applicant: Intermedics Orthopedics
• Product Code: KWT · Orthopedic
• Decision Date: Feb 27, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3650
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Select Shoulder Curved-back Pegged All-Poly Glenoids, when used with one of the Select Shoulder Humeral Stems and Humeral Heads, are intended only for use with bone cement in cases of total shoulder arthroplasty for treatment of the following: 1. Patient conditions, including but not limited to, noninflammatory degenerative joint disease (NIDJD), e.g., osteoarthritis or post-traumatic arthritis, and inflammatory joint disease (IJD), e.g., rheumatoid arthritis. 2. Complex acute fractures, fracture-dislocations of the humeral head, malunion or nonunion of a small osteoporotic head fragment, chronic, recurrent or acute dislocation with loss of humeral head cartilage, or large impression fractures. 3. Those patients with failed previous surgery where pain, deformity, or dysfunction persists. 4. Failed previous surgery, including joint reconstruction, internal fixation, nonunion of the humeral neck, arthrodesis or hemiarthroplasty. 5. Cuff tear arthropathy. 6. Avascular necrosis or osteonecrosis of the humeral head. 7. Tumor resection.

Device Story

Glenoid prosthesis; one-piece polyethylene design; replaces natural glenoid surface in total shoulder arthroplasty. Implanted via bone cement into subchondral bone; provides 1-2 mm cement mantle. Features curved articulating surface; two grooved pegs with dovetail cement grooves for stability/fixation; pegs trimmable intraoperatively for shallow glenoid vaults. Titanium x-ray marker pins included for postoperative evaluation. Used in clinical setting by orthopedic surgeons. Nonconstrained articulating geometry allows range of motion and translation. Benefits patient by restoring joint function and reducing pain associated with degenerative or traumatic shoulder conditions.

Clinical Evidence

Bench testing only. Contact area testing performed to evaluate performance at various levels of abduction, demonstrating adequate contact area.

Technological Characteristics

Polyethylene (ASTM F648) glenoid component; titanium (ASTM F136) x-ray marker pins. Nonconstrained articulating geometry. Pegged fixation with dovetail cement grooves. Cemented implantation.

Indications for Use

Indicated for patients requiring total shoulder arthroplasty due to NIDJD (osteoarthritis, post-traumatic arthritis), IJD (rheumatoid arthritis), complex acute fractures, fracture-dislocations, malunion/nonunion, chronic/recurrent dislocation, impression fractures, failed previous surgery (reconstruction, fixation, arthrodesis, hemiarthroplasty), cuff tear arthropathy, avascular/osteonecrosis, or tumor resection.

Regulatory Classification

Identification

A shoulder joint metal/polymer non-constrained cemented prosthesis is a device intended to be implanted to replace a shoulder joint. The device limits minimally (less than normal anatomic constraints) translation in one or more planes. It has no linkage across-the-joint. This generic type of device includes prostheses that have a humeral component made of alloys, such as cobalt-chromium-molybdenum, and a glenoid resurfacing component made of ultra-high molecular weight polyethylene, and is limited to those prostheses intended for use with bone cement (§ 888.3027).

Special Controls

*Classification.* Class II. The special controls for this device are:(1) FDA's: (i) “Use of International Standard ISO 10993 ‘Biological Evaluation of Medical Devices—Part I: Evaluation and Testing,’ ” (ii) “510(k) Sterility Review Guidance of 2/12/90 (K90-1),” (iii) “Guidance Document for Testing Orthopedic Implants with Modified Metallic Surfaces Apposing Bone or Bone Cement,” (iv) “Guidance Document for the Preparation of Premarket Notification (510(k)) Application for Orthopedic Devices,” and (v) “Guidance Document for Testing Non-articulating, ‘Mechanically Locked’ Modular Implant Components,” (2) International Organization for Standardization's (ISO): (i) ISO 5832-3:1996 “Implants for Surgery—Metallic Materials—Part 3: Wrought Titanium 6-Aluminum 4-Vandium Alloy,” (ii) ISO 5832-4:1996 “Implants for Surgery—Metallic Materials—Part 4: Cobalt-Chromium-Molybdenum Casting Alloy,” (iii) ISO 5832-12:1996 “Implants for Surgery—Metallic Materials—Part 12: Wrought Cobalt-Chromium-Molybdenum Alloy,” (iv) ISO 5833:1992 “Implants for Surgery—Acrylic Resin Cements,” (v) ISO 5834-2:1998 “Implants for Surgery—Ultra-high Molecular Weight Polyethylene—Part 2: Moulded Forms,” (vi) ISO 6018:1987 “Orthopaedic Implants—General Requirements for Marking, Packaging, and Labeling,” and (vii) ISO 9001:1994 “Quality Systems—Model for Quality Assurance in Design/Development, Production, Installation, and Servicing,” and (3) American Society for Testing and Materials': (i) F 75-92 “Specification for Cast Cobalt-28 Chromium-6 Molybdenum Alloy for Surgical Implant Material,” (ii) F 648-98 “Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants,” (iii) F 799-96 “Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Forgings for Surgical Implants,” (iv) F 1044-95 “Test Method for Shear Testing of Porous Metal Coatings,” (v) F 1108-97 “Titanium-6 Aluminum-4 Vanadium Alloy Castings for Surgical Implants,” (vi) F 1147-95 “Test Method for Tension Testing of Porous Metal Coatings,” (vii) F 1378-97 “Specification for Shoulder Prosthesis,” and (viii) F 1537-94 “Specification for Wrought Cobalt-28 Chromium-6 Molybdenum Alloy for Surgical Implants.”

Predicate Devices

• Select Shoulder Pegged All-Poly Glenoids
• Keeled All-Poly Glenoids

Reference Devices

• Orthomet/3M Modular Neer II Shoulder System
• Zimmer Fenlin Total Shoulder
• Smith & Nephew Richards Cofield Shoulder
• Kirschner/Biomet Modular Shoulder
• Biomet Bio-Modular Total Shoulder
• Depuy Global Total Shoulder System

Submission Summary (Full Text)

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K970567

510(k) SUMMARY

February 13, 1997

FEB 27 1997

In accordance with the Food and Drug Administration Interim Rule to implement provisions of the Safe Medical Devices Act of 1990 and in conformance with 21CFR 807, this is to serve as a 510(k) Summary for the Sulzer Orthopedics Inc. Select® Shoulder Curved-back Pegged All-Poly Glenoids.

Submitter: Sulzer Orthopedics Inc.
9900 Spectrum Drive
Austin, TX 78717
[phone]

Contact Person: Jacquelyn Hughes
Regulatory Affairs Manager

Classification Name: 21 CFR Part 888.3650 - Shoulder joint metal/polymer non-constrained cemented prosthesis

Common/Usual Name: Glenoid prosthesis

Trade/Proprietary: Select® Shoulder Curved Back Pegged All-Poly Glenoids

## Product Description/Substantial Equivalence:

The Curved-back Pegged All-Poly Glenoid is a one piece, polyethylene (ASTM F648) design intended to reproduce the function of the natural glenoid. The design is such that the component may be used in either the right or left shoulder. The implant is cemented into the subchondral bone of the glenoid cavity providing a cement mantle of approximately 1-2 mm.

This design features a curved articulating surface. The underside of the component has two grooved pegs bounded by two dovetail cement grooves which provide translational and rotational stability to the implant as well as to enhance cement fixation. The grooves in the pegs also allow the surgeon to intraoperatively trim the length in the event that the glenoid vault is shallow and prevents the full length from being seated. Titanium (ASTM F136) x-ray marker pins are incorporated in the superior and inferior aspects of the component to assist in postoperative evaluation. The lateral surface of the glenoid component accommodates the humeral head. The articulating geometry is nonconstrained for greater range of motion and greater translation.

Contact area testing indicates that the Curved-back Pegged All-Poly Glenoids offer adequate contact area at various levels of abduction.

The designs are substantially equivalent to the Select Shoulder Pegged All-Poly Glenoids and Keeled All-Poly Glenoids as well as those glenoids used in the Orthomet/3M Modular Neer II Shoulder System, the Zimmer Fenlin Total Shoulder, the Smith & Nephew Richards Cofield

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Shoulder, the Kirschner/Biomet Modular Shoulder, the Biomet Bio-Modular Total Shoulder, and the Depuy Global Total Shoulder System.

The Select Shoulder Curved-back Pegged All-Poly Glenoids, when used with one of the Select Shoulder Humeral Stems and Humeral Heads, are intended only for use with bone cement in cases of total shoulder arthroplasty for treatment of the following:

1. Patient conditions, including but not limited to, noninflammatory degenerative joint disease (NIDJD), e.g., osteoarthritis or post-traumatic arthritis, and inflammatory joint disease (IJD), e.g., rheumatoid arthritis.
2. Complex acute fractures, fracture-dislocations of the humeral head, malunion or nonunion of a small osteoporotic head fragment, chronic, recurrent or acute dislocation with loss of humeral head cartilage, or large impression fractures.
3. Those patients with failed previous surgery where pain, deformity, or dysfunction persists.
4. Failed previous surgery, including joint reconstruction, internal fixation, nonunion of the humeral neck, arthrodesis or hemiarthroplasty.
5. Cuff tear arthropathy.
6. Avascular necrosis or osteonecrosis of the humeral head.
7. Tumor resection.